The Draft Patent Law

Intellectual Property and Patents

Article Snapshot

Author(s)

Frederick M. Abbott, Amy Kapczynski and T. N. Srinivasan

Source

Op-Ed in The Hindu, Chennai, India, March 12, 2005

Summary

This article addresses the changes to India’s patent regulations that needed to be made under the TRIPS agreement.

Policy Relevance

Under the TRIPS agreement, India agreed to adopt a full patent protection system, including protection of pharmaceutical drugs by 2005. However, India’s strong generic drug market needs to be protected as much as is allowed under the treaty in order to prevent spikes in drug costs and inequality in access to medically necessary drugs.

Main Points

  • Patent protection exists to encourage innovation, but comes with the cost of higher prices to consumers. Historically, different countries varied substantially in the type and amount of patent protection offered.
     
  • In 1994, an international agreement was reached in order to simplify international patent law. This treaty was called the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS).
     
  • The TRIPS agreement mandated uniform, American style, patent systems to be adopted by all participating countries. In regards to India, the agreement required adoption of the basic system by January 1, 2000, with full protection extending to pharmaceuticals and agricultural chemicals by 2005.
     
  • Previously, India did not provide patent protection for pharmaceutical drugs, which resulted in India’s strong generic drug system and substantially reduced the cost of medically necessary drugs. However, many critics of patent protection are concerned that implementation of the TRIPS agreement will undo this progress.
     
  • Four specific recommendations, if adopted by the Indian Parliament, should help to ensure protection of India’s generic industry and citizenry.
    • Parliament should only allow patents for new chemical entities and for modifications that show significant improvement, thus preventing companies with existing drug patents from continually renewing the life of their drugs via minor chemical changes.
       
    • Indian law should retain maximum flexibility on how to deal with compulsory licensing, which forces patent holders to allow other entities limited use of their patented material.
       
    • A pre-grant opposition right should be created by Parliament, which would allow for challenging patent applications before they are granted.
       
    • Finally, Parliament should consider entering into a global exhaustion regime, which would allow medications lawfully sold in another country to be imported to India. Other large countries, such as the U.S., have considered such options in order to reduce drug prices.
       
  • These recommendations, all of which are permissible under the TRIPS agreement, would help to prevent the possible negative impacts that could otherwise be created by implementation of Indian patent reform in regard to pharmaceuticals.
     

 

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